PARAVEGANIO 500 mg tablets, 20 pcs

Instructions for use for PARAVEGANIO 500 mg tablets, 20 pcs

Application notes

Children from 4-8 years with 17-25 kg body weight	1/2 Tablet	1-4 times a day (max. 2 tablets a day)	at a distance of 6 hours, regardless of the meal
Children from 8-11 years with 26-32 kg body weight	1/2 Tablet	1-6 times a day (max. 3 tablets a day)	at a distance of 6 hours, regardless of the meal
Children from 11-12 years with 33-43 kg body weight	1 Tablet	1-4 times a day (max. 4 tablets a day)	at a distance of 6 hours, regardless of the meal
Young people from 12 years and adults over 43 kg body weight	1-2 Tablets	1-4 times a day (max. 8 tablets a day)	at a distance of 6 hours, regardless of the meal

Application areas

Mode of action

How does the ingredient of the medicine work?

The active ingredient has a pain relieving and fever -lowering. It also has low anti -inflammatory properties. He blocks the formation of certain messenger substances in the body, so -called prostaglandins. These are significantly involved in the development of pain, fever and inflammation.

Composition

Contradictions

What speaks against an application?

Always:
- Hypersensitivity to the ingredients

Under certain circumstances - speak to your doctor or pharmacist:
- Restricted liver function (e.g. by chronic alcohol abuse or inflammation of the liver)
- Limited kidney function
- Gilbert syndrome (Meulengracht disease)
- Alcohol abuse
- Hereditary enzyme disorder (glucose-6-phosphate dehydrogenase deficiency)
- Anemic wise by faster reducing red blood cells (hemolytic anemia)
- Glutathione deficiency
- Lack of fluid
- Malnutrition

Which age group must be observed?
- Children under 4 years: The medicine should generally not be used in this group. There are preparations that are more suitable from the active ingredient strength and/or dosage form.

What about pregnancy and lactation?
- Pregnancy: Contact your doctor. Various considerations play a role, whether und how the drug can be used during pregnancy.
- Still -time: According to current knowledge, there is no evidence that the medicine must not be applied during breastfeeding.

If the medicine has been prescribed to you despite a counter -notification, speak to your doctor or pharmacist. The therapeutic benefit can be higher than the risk of using the application.

Side effects

What adverse effects may occur?

For the medicine, only side effects are described that have so far only occurred in exceptional cases.

If you notice a disorder or change during treatment, contact your doctor or pharmacist.

For information at this point, side effects are taken into account that occurs in at least one of 1,000 patients treated.

Hints

What should you consider?
- Do not apply longer for pain or fever without medical advice than specified in the package insert!
- With permanent use of pain relievers, headaches can occur, which are generated by the pain reliever. Talk to your doctor to prevent your headache from becoming chronic.
- The habitual use of painkillers can lead to permanent kidney damage. If several pain relievers are combined, or if there are several active ingredients in a pain reliever, the risk increases.
- Attention: With regular or high alcohol enjoyment, existing liver damage can lead to life -threatening conditions if the drug is also used.
- Beware of allergy to painkillers!
- There can be medicinal products with which interactions occur. Therefore, you should generally provide the doctor or pharmacist before treatment with a new medicine. This also applies to medicines that you buy yourself, only apply occasionally or that the application has been available for some time.

Detailed instructions for PARAVEGANIO 500 mg tablets, 20 pcs

Field of use

• The preparation is a pain relieving, fever -lowering medicine (analgesic and antipyretics).
• It is used for symptomatic treatment of light to moderately severe pain such as headache, toothache, menstrual pain and/or fever.

Active ingredients / ingredients / ingredients

500 mg paracetamol
Cellulose, microcrystalline auxiliary material (+)
Magnesium stair (Ph. EUR.) [pflanzlich] Hedge substance (+)
Corn starch auxiliary substance (+)
Povidon auxiliary substance (+)

Contradictions

• The medicine must not be taken
  • if you are allergic to paracetamol or one of the other components of this medicine.

dosage

• Always take this medicine exactly as described or follow your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure.
• The dosage is based on the information in the following table. Paracetamol is dosed depending on body weight (kg) and age, usually with 10 - 15 mg / kg kg as a single dose, up to a maximum of 60 mg / kg kg as a total dose of daily dose.
• The respective dosage interval depends on the symptoms and the maximum total daily dose. It shouldn't fall below 6 hours.
• In the event of complaints that last for more than 3 days, a doctor should be consulted.
  • Body weight (age): 17 - 25 kg (children from 4 - 8 years)
    • Single dose in the number of tablets (corresponding paracetamy dose)
      • 1/2 Tablet (corresponding to 250 mg paracetamol)
    • Maximum daily dose (24 hours) in number of tablets (corresponding paracetam gold dose)
      • 2 (4 times 1/2) tablets (corresponding to 1,000 mg paracetamol)
  • Body weight (age): 26 - 32 kg (children from 8 - 11 years)
    • Single dose in the number of tablets (corresponding paracetam gold dose)
      • 1/2 Tablet (corresponding to 250 mg paracetamol)*
    • Maximum daily dose (24 hours) in number of tablets (corresponding paracetam gold dose)
      • 2 (4 times 1/2) tablets (corresponding to 1,000 mg paracetamol)**
  • Body weight (age): 33 - 43 kg (children from 11 - 12 years)
    • Single dose in the number of tablets (corresponding paracetamy dose)
      • 1 Tablet (corresponding to 500 mg paracetamol)
    • Maximum daily dose (24 hours) in number of tablets (corresponding paracetam gold dose)
      • 4 Tablets (corresponding to 2,000 mg paracetamol)
  • Body weight (age): from 43 kg (children and adolescents from 12 years and adults)
    • Single dose in the number of tablets (corresponding paracetamy dose)
      • 1 - 2 Tablets (corresponding to 500 - 1,000 mg paracetamol)
    • Maximum daily dose (24 hours) in number of tablets (corresponding paracetam gold dose)
      • 8 Tablets (corresponding to 4,000 mg paracetamol)
  • * Other dosage forms may be more advantageous for this patient group, since they enable a maximum dosage of a maximum of 400 mg paracetamol.
  • ** In exceptional cases, up to 3 (6 times 1/2) tablets can be taken daily in a dosage interval of at least 4 hours. H. Up to 1,500 mg paracetamol daily.
• The maximum daily dose (24 hours) specified in the table must never be exceeded.

 

• Duration of the application
  • Do not take paracetamol for more than 3 days without medical or dental advice.

 

• Special patient groups
  • Liver dysfunction and easy restriction of kidney function
    • In patients with liver or kidney dysfunction and Gilbert syndrome, the dose must be reduced or the distance between the individual doses must be extended.
    • A daily total dose of 2 g must not be exceeded without medical instruction.
  • Heavy renal insufficiency
    • In the case of severe renal insufficiency (creatinine clearance < 10 ml/min), the distance between the individual doses must be at least 8 hours.
    • Unless otherwise prescribed, dose reduction is recommended in patients with renal failure. The distance between the individual doses must be at least 6 hours, see table:
      • Adult:
        • glomerular filtration rate: 10 - 50 ml / min
          • Dose: 500 mg every 6 hours
        • glomerular filtration rate: < 10 ml / min
          • Dose: 500 mg every 8 hours
  • Older patients
    • Experience has shown that no special dose adjustment is required.
    • However, a reduction in the dose or extension of the dosage interval may be necessary for weakened, immobilized older patients with restricted liver or kidney function.
  • Without medical instruction, the maximum daily dose of 60 mg / kg body weight (up to a maximum of 2 g / day) should not be exceeded at:
    • Body weight below 50 kg
    • chronic alcoholism
    • Water deprivation
    • chronic malnutrition
  • Children and adolescents with low body weight
    • Using the preparation in children under 4 years or under 17 kg body weight is not recommended, since the dose of strength is not suitable for this patient group. However, suitable dose strengths or dosage forms are available for this patient group.

 

• If you have taken a larger amount than you should
  • In order to prevent the risk of overdose, it should be ensured that other medicines that are used at the same time do not contain paracetamol.
  • The total dose of paracetamol may not exceed 4,000 mg paracetamol (corresponding to 8 tablets) daily for adults and adolescents from the age of 12 or from 43 kg body weight and 60 mg / kg kg per day.
  • In the event of an overdose, there are generally complaints within 24 hours that include nausea, vomiting, loss of appetite, pallions and abdominal pain.
  • If a larger amount of paracetamol has been taken than recommended, call den next accessible doctor for help!

 

• If you have forgotten the intake
  • Do not take the double amount if you have forgotten the prior intake.

 

• If you have any further questions about taking this medicine, please contact your doctor or pharmacist.

Taking

• The medicine is taken with plenty of liquid. Taking it after meals can lead to a delayed occurrence.

Patient information

• Warnings and Precautions
  • Please speak to your doctor or pharmacist before taking the medicine
    • if you are chronically alcoholic
    • if you suffer from the impairment of liver function (liver inflammation, Gilbert syndrome)
    • with pre -damaged kidney
    • if medication is taken at the same time, that impair liver function
    • in the event of an inherited lack of the enzyme glucose-6-phosphate dehydrogenase, which can lead to severe anemia, also called favism
    • in hemolytic anemia (anemia due to a decay of the red blood cells)
    • in the event of a lack of glutathione protein involved in the liver metabolism (e.g. in the event of malnutrition, alcohol abuse, diabetes mellitus, HIV, down syndrome, tumors)
    • in the event of a lack of liquid in the body (dehydration) z. B. due to small amount of drinking, diarrhea or vomiting
    • in chronic malnutrition
    • with a body weight of less than 50 kg
    • with higher age
  • If your symptoms worsen or no improvement occurs after 3 days or if you have a high fever you have to see a doctor.
  • In order to prevent the risk of overdose, it should be ensured that other medicines that are used at the same time do not contain paracetamol.
  • If painkillers are not dosed for a long time, headaches can occur, which may not be treated by increased doses of the drug.
  • In general, the habitual intake of pain relievers, especially when combining several pain relieving active ingredients, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy).
  • When stopping abruptly, headaches and fatigue, muscle pain, nervousness and vegetative symptoms can occur after a long -dosed, non -determined use of painkillers. The deductible symptoms subside within a few days. Until then, painkillers are to be reinforced and the revenue should not take place without medical advice.
  • Paracetamol does not take for a long time or in higher doses without medical or dental advice.
  • Taking the total daily dose once can lead to severe liver damage; In such a case, medical help should be consulted immediately.

 

• Wateriness and ability to operate machines
  • Paracetamol has no influence on the traffic and operating machines.
  • Nevertheless, caution is always required after taking a pain reliever.

Pregnancy

• If you are pregnant or breastfeed, or if you suspect that you are pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this drug.
• Pregnancy
  • The preparation should only be taken after strict consideration of the benefit risk ratio during pregnancy.
  • You should not take paracetamol during pregnancy for a long time, in high doses or in combination with other medicines, since the safety of the application is not proven for these cases.
• Breastfeeding
  • Paracetamol passes into breast milk. Since adverse consequences for the infant have not yet become known, an interruption of breastfeeding will generally not be necessary.

Hints

Do not apply longer for pain or fever without medical advice than specified in the package insert!

Manufacturer:  axunio Pharma GmbH, Van-der Smissen-Straße 1, 22767 Hamburg